Boston Scientific recalls 22 units of Five IceRod i-Thaw Prostate Cryoablation Kit due to reported needle shaft gas leaks. Consumers should contact the company for details.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 22 units of the Five IceRod i-Thaw Prostate Cryoablation Kit because of complaints about needle shaft gas leaks. This could potentially cause injury during medical procedures.
The needle shaft in the kit may leak gas, which could cause unintended tissue damage during medical procedures. This is a reported issue but not confirmed to cause serious injury in normal use.
Patients undergoing prostate cryoablation procedures who own the recalled kit are affected. Medical professionals using the kit are at risk if they have the recalled units.
Check for the product name 'Five IceRod i-Thaw Prostate Cryoablation Kit' with the batch numbers listed: U1264, U1226, U1089, U1012, U1009, U0827, U0772, U0767, U0491, T0817, T0693, T0725, T0587, T0487, T0486, T0313, A7114, A6823, A2113, A1942, A1712, A1257, A1252.
Identify the batch numbers on the kit to see if it matches the recalled units listed: U1264, U1226, U1089, U1012, U1009, U0827, U0772, U0767, U0491, T0817, T0693, T0725, T0587, T0487, T0486, T0313, A7114, A6823, A2113, A1942, A1712, A1257, A1252.
22 units of the Five IceRod i-Thaw Prostate Cryoablation Kit.
Complaints about needle shaft gas leaks, which could potentially cause unintended tissue damage during medical procedures.
The recall does not specify a stop-use action; check the batch numbers to see if your unit is affected.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0690-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0690-2021 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
